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The U.S. District Court for the District of Maryland ruled Sept. 27 that Elan's provision
of information on the safety and efficacy of the underlying drug, metaxalone, to the
Food and Drug Administration falls within the “safe harbor” of the Hatch-Waxman Act.

The safe harbor is important to companies on both sides of patent litigation because
it can exempt from liability infringing activity that's “reasonably related to the
development and submission of information” to the FDA.

Brand and generic manufacturers have been battling over the limits of the safe harbor
provision for the past eight years, resulting in arguably conflicting decisions by
the U.S. Court of Appeals for the Federal Circuit, particularly regarding activities
conducted after FDA approval.

Classen's 12-year-old case is likely ended with the decision, as the Federal Circuit,
in effect, guided the district court to this conclusion.

Post-Approval Actions Covered by Safe Harbor

The Hatch-Waxman safe harbor provision in question,
35 U.S.C. §271(e)(1)
, provides an exception for otherwise infringing acts, usually by generic makers.
But under Federal Circuit law, it can extend to brand name makers as well.

Here, the FDA approved Elan's new drug application (NDA) for Skelaxin in 2001. Responding
to a third party's data, though, the FDA sought Elan's feedback on a proposal to change
the drug label. Elan conducted a clinical trial to characterize the effect of food
on the absorption of metaxalone and submitted that information to the FDA to revise
Skelaxin's product label and to propose changes to the approval requirements for generic
versions of the drug.

Classen asserted U.S. Patent No.
6,584,472
, alleging infringement by the study, the information that would be on the label and
Elan's activities related to filing for new patents in light of what it learned in
the study.

In 2012, the district court granted summary judgment in favor of Elan under the safe
harbor, not reaching decisions on infringement or validity. The Federal Circuit affirmed
and remanded only because the original district court opinion didn't say enough about
whether some of Elan's activities met the “reasonably related” characterization.
Classen Immunotherapies v. Elan Pharms., Inc., 786 F.3d 892, 114 U.S.P.Q.2d 1920 (Fed. Cir. 2015) (13 PLIR 731, 5/22/15).

Following Federal Circuit's Script

On remand, Judge Richard D. Bennett quoted extensively from “observations of the record”
in the Federal Circuit's opinion that detailed how it expected the district court
to assess those other activities.

Classen argued that “reanalyzing the clinical data to identify patentable information
and filing patent applications” is aimed at commercialization and so is outside of
the safe harbor. But Bennett simply restated the appeals court's caution that filing
patent applications is not a commercial event.

He also rejected Classen's contention that a revised Skelaxin label was integral to
making and selling the product. Bennett said that the safe harbor can apply to the
disclosure and use of clinical study results “even for purposes other than regulatory
approval.” Elan's use of the data here was far less “commercial” in nature than prior
cases that have invoked the safe harbor, he said.

The judge further said that even if Classen's claims weren't barred as a matter of
law, it still hadn't raised a genuine issue of material fact regarding infringement.

“Here, with discovery long complete and this case having worn on for nearly twelve
years, Classen has produced no evidence of Elan’s alleged reanalysis of the data for
commercial purposes so as to raise a genuine issue of material fact regarding Elan’s
infringement,” Bennett said.

Elan is now part of Dublin-based Perrigo Co. plc. Bloomberg BNA contacted Perrigo's
U.S. subsidiary, Allegan, Mich.-based Perrigo Co., Sept. 28, but the company declined
to comment on the ruling. Bloomberg BNA also contacted Baltimore-based Classen but
no one was available to comment.

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